Safety and Efficacy of Relestat Ophthalmic Solution 0.05% for Allergic Conjunctivitis in Korea

Completed

• Conditions: Conjunctivitis, Allergic
• Interventions: Drug: Relestat Ophthalmic Solution 0.05%

• Registration Number: NCT01987765
• Lead Sponsor: Allergan

Brief Summary

This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Relestat Ophthalmic Solution 0.05% in patients with allergic conjunctivitis who are treated with Relestat as standard of care in clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-19
• Status Verified: 2014-03
• Results First Submitted: 2014-03-26
• Results First Submitted QC: 2014-03-26
• Last Update Submitted: 2014-03-26
• Results First Posted: 2014-04-29
• Last Update Posted: 2014-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 847

Inclusion Criteria

• Patients with Allergic Conjunctivitis treated with Relestat Ophthalmic Solution in clinical practice.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Relestat Ophthalmic Solution 0.05%	Relestat Ophthalmic Solution 0.05%	Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale	Baseline, 2 Weeks	Itchiness, conjunctival hyperaemia (redness), lacrimation (tearing), and foreign body sensation were each evaluated on a 4-point scale ranging from 0 (best) to 3 (worst). The eye symptom total score is the sum of the individual symptom scores and ranges from 0 (best) to 12 (worst). A negative number change from baseline indicates an improvement.
Percentage of Patients Reporting Adverse Events	Up to 10 Months	An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.